Nowhere in the white paper does MITA provide support for its claim of an increased "risk to the public health." As MITA once acknowledged in its previous submission to the FDA it is impossible to provide a statistically valid analysis of the extent of problems.
MITA should maybe take a little guidance from Groundhog Day with respect to its white paper. Phil Connors was eventually able to get out of the time loop by adopting a new attitude which truly focused on improving the lives of those around him (movie spoiler: saving a boy falling from a tree, helping a restaurant patron choking and fixing the flat tire of elderly ladies etc.). Accordingly, perhaps adding some manufacturer responsibilities, can assist this recommendation:
- Perhaps they could have included in the white paper an affirmative duty of the manufacturer to provide "adequate instructions"?
- How about if there are specifications or performance standards, or components that would only be measured or quantified during the course of scheduled maintenance, requiring the manufacturer to provide this information?
- If there are specifications available for component replacements, why not ask the manufacturer to share this information? Why not ask the manufacturer to routinely disclose, for parts and components, the preventive maintenance instructions, especially for those parts or components that may experience measurable degrees of wear?
- If the manufacturer requires custom test equipment to calibrate or service an imaging system, shouldn’t that testing equipment be made available for sale?
Is it really enough to simply say one needs a robust QMS? Remember the final lesson of GroundHog Day: Phil was finally able to succeed in escaping the time loop and getting his love interest Rita to truly appreciate him after he started doing things to support the community.
About the author: Robert J. Kerwin is general counsel for IAMERS, the International Association of Medical Equipment Remarketers and Servicers.Back to HCB News
